Capturing Real-World Evidence

Rachael Fleurence wants to harness digital data to evaluate the effectiveness of medical equipment and supplies

Rachael Fleurence

Using real-world evidence – not just manufacturer-sponsored studies – to make decisions about the safety, efficacy and value of medical equipment and devices sounds simple and sensible. It does make sense. But simple? Not so much.

But that isn’t stopping a group of researchers, health systems and manufacturers from exploring ways to collect and analyze real-world evidence about medical devices. Their work will very likely affect decision-makers at the U.S. Food and Drug Administration, vendors, and supply chain and contracting professionals.

Clinical trials have always been – and remain – the gold standard for evidence-gathering, because data is carefully collected, controlled and monitored. The problem is, such trials can be narrow in scope due to practical challenges (particularly, time and money). What’s more, they cannot always help regulators or providers predict how a medical device or piece of equipment will perform over time, after day-to-day usage.

“Devices are often used in routine clinical practice for uses that are not within their cleared or approved indications for use,” pointed out the FDA in August 2017, in its non-binding recommendations concerning the use of real-world evidence. “However, the knowledge gained from all uses of a device in medical practice is often not realized because the data collected are not systematically characterized, aggregated, and analyzed in a way that can be relied upon to inform regulatory decision-making.”

The question is, how can regulatory agencies and healthcare providers harness the wealth of digital data from electronic health records, insurance claims, registries, etc., to reliably evaluate the effectiveness and value of medical equipment and supplies? That’s what the National Evaluation System for health Technology Coordinating Center (NESTcc) is working on.

A Planning Board convened by the Duke-Margolis Center for Health Policy in late 2015 envisioned NEST as a voluntary network of data partners who could consolidate real-world evidence to inform medical device evaluation. In September 2016, the FDA awarded a grant for the NEST Coordinating Center to the Medical Device Innovation Consortium (MDIC), a non-profit, public-private partnership that works to promote patient access to innovative medical technologies. In April 2017, health economist Rachael Fleurence, PhD, was named executive director of NESTcc.

She came to NESTcc with 15 years of research experience regarding health outcomes and cost-effectiveness, including seven years in the life sciences consulting industry. Just prior to joining NESTcc, she was a program director at the Patient-Centered Outcomes Research Institute, or PCORI.

Not just any data set
Health systems collect real-world patient data every day, many for internal purposes, such as quality control, says Fleurence. In some cases, they may share that information with a specific device or equipment manufacturer.

But NEST is interested in using real-world data for research purposes, she says In that case, the data collected must be of a higher quality. “You can’t just use any data set; it needs special attention.”

NESTcc is collaborating with 12 providers and payers, representing almost 200 hospitals and 4,000 outpatient clinics, all of whom are capable of generating high-quality data.

In February 2018, Fleurence and NESTcc announced eight demonstration projects, or test cases, involving those collaborators and industry partners. Participants are exploring how they can share real-world data efficiently and cost-effectively, and how they can overcome the many challenges in doing so, including the lack of Unique Device Identifiers (UDIs) and the inconsistency in patient-reported outcomes.

The projects are being executed through collaborations with industry partners Abbott, Adhesys Medical, Johnson & Johnson Medical Devices Companies, and W.L. Gore & Associates, Inc. In addition to the manufacturers, the American Academy of Orthopaedic Surgeons (AAOS) is serving as a neutral convener, bringing together DJO Global, DePuy Synthes, Smith & Nephew, Stryker, and Zimmer Biomet for a test case that will bring together NESTcc Network Collaborators with the American Joint Replacement Registry (AJRR) which is housed at AAOS.

“It definitely is possible” to overcome the challenges of compiling and analyzing real-world data, says Fleurence. “We’re in a transition phase, from the old world to the new world. We will reach a point where this will be done seamlessly, and we will have data to analyze how patients are doing with specific implants, for example.

“Will every institution be at the same level at the same time? No. But we are seeing bright spots – examples of studies that were not possible before. And that will keep scaling up. It’s definitely happening.

“We are building NEST to answer questions for a number of different parties – first, the FDA, industry and payers, but also patient groups and health systems, so they can determine the value and effectiveness of the medical devices they are using,” she continues.

“We haven’t prioritized the question, ‘How can supply chain use real-world data when selecting medical devices and equipment?’” she says. “But we are building NESTcc so that, ultimately, providers will be able to answer that question directly.”

A definition of terms

Real-world data (RWD) are data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Examples include data derived from electronic health records (EHRs), claims and billing data, data from product and disease registries, patient-generated data including in-home-use settings, and data gathered from other sources that can inform on health status, such as mobile devices.


Real-world evidence (RWE) is the clinical evidence regarding the usage, and potential benefits or risks, of a medical product derived from analysis of RWD. Under the right conditions, data derived from real-world sources can be used to support regulatory decisions. RWD and associated RWE may constitute valid scientific evidence depending on the characteristics of the data, though it doesn’t replace FDA’s regulatory-decision-making evidentiary standards

Source: “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food and Drug Administration Staff,” U.S. Food and Drug Administration, Aug. 31, 2017

Demonstration projects

The NESTcc demonstration projects are intended to address the following disease areas and corresponding products.

Application Project title Disease area
Pre-market submission Comparative effectiveness of alternative approaches for wound closure Dermatology
Label expansion Testing the use of real-world data from three unique sources to expand indications Vascular
Label Expansion The feasibility of using real-world data in the evaluation of cardiac ablation catheters Cardiology
Label expansion Real-world clinical outcomes in patients with mechanical heart valve replacement and anticoagulation variability Cardiology
Label from general to specific indication Feasibility of using real-world data to evaluate thermal ablation of liver tumors Surgery
Postmarket surveillance Testing the feasibility of registry and claims data linkages Orthopedics
Postmarket surveillance Developing capacity to conduct proactive post-marketing safety surveillance of craniomaxillofacial distractors using electronic health record data

Capacity to Conduct Proactive Post Marketing Safety Surveillance of Craniomaxillofacial Distractors Using Electronic Health Record Data

Postmarket surveillance Developing Capacity to Conduct Proactive Post Marketing Safety Surveillance of Intervertebral Body Fusion Devices Using Electronic Health Record Data Orthopedics

For a description of each test case, visit:


NESTcc collaborators

NESTcc is growing its relationship with network collaborators to advance the use of Real-World Evidence (RWE) generation and foster collaboration with stakeholders across the medical device field. To date, memoranda of understanding (MOUs) have been signed with 12 network collaborators. Together, they represent more than 195 hospitals and 3,942 outpatient clinics. Network collaborators have access to over 494 million patient records, and available data sources include electronic health records (EHRs), pharmacies, public and private claims, registries, and patient-generated data.

  • Duke University Health System
  • HealthCore
  • Lahey Hospital & Medical Center
  • Mayo Clinic
  • MDEpiNet
  • Mercy Health
  • STAR
  • University of Florida Health System
  • PEDSnet
  • Vanderbilt University Medical Center
  • Weill-Cornell Medicine
  • Yale New Haven Health System
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